NCT01933217

Methylphenidate for Attention Problems After Pediatric TBI

Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Traumatic Brain Injury (TBI) - methylphenidate treatment

Detailed description

The objectives of the study are to (1) determine the efficacy and dose-response of methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI) and (2) provide a better understanding of the relationship of a prior history of attention deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and attentional control to treatment efficacy. The proposed clinical trial will enroll 50 children, age 6-17 years, with attention problems \>6 months after moderate to severe TBI into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose conditions (low, medium, and high).

Conditions

• Traumatic Brain Injury
• TBI
• ADHD

Interventions

Type	Name	Description
DRUG	Methylphenidate
DRUG	Placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-09-02
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

1 site across 1 country: United States